In the news

On April 29, 2024, the FDA took action aimed at helping to ensure the safety and effectiveness of laboratory developed tests, or LDTs, which are used in a growing number of healthcare decisions and about which concerns have been raised for many years. The FDA announced a final rule today amending the FDA’s regulations to make explicit that IVDs are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Historically, the FDA has generally exercised enforcement discretion for most LDTs, meaning that the agency has not enforced applicable requirements concerning most LDTs. Now, many LDTs are widely used for a larger and more diverse population, with large laboratories accepting specimens from across the country. The FDA is aware of numerous examples of potentially inaccurate, unsafe, ineffective, or poor quality IVDs offered as LDTs that caused or may have caused patient harm. “Today’s action is a critical step toward helping to ensure the safety and effectiveness of LDTs while also taking into account other public health considerations, including continued access to critical tests patients rely upon,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. @ https://www.fda.gov/news-events/press-announcements/fda-takes-action-aimed-helping-ensure-safety-and-effectiveness-laboratory-developed-tests?utm_medium=email&utm_source=govdelivery

The CFIA reported that Jue Wei Food (Canada) Ltd., a Delta, British Columbia Company, recalled prepared Kingwuu and T&T Kitchen Beancurd, Beef, Duck, Goose, and Pork products from the Canadian marketplace due to suspected Listeria monocytogenes contamination. There have been no reported illnesses associated with the consumption of these products. The Beancurd, Beef, Duck, Goose, and Pork products were distributed and sold in the Canadian provinces of Alberta and British Columbia.@ https://recalls-rappels.canada.ca/en/alert-recall/kingwuu-brand-and-tt-kitchen-brand-meat-and-vegetable-products-recalled-due-listeria

The FDA reported that Tama Corporation (Doral FL) recalled 24-ounce containers of “Queso de Mano PAISA” due to contamination with Listeria monocytogenes. Tama Corporation was informed by the co-packer of QUESO DE MANO PAISA that a batch of 18 cases distributed in Salt Lake City, Utah, was suspicious of Listeria monocytogenes contamination. As a result, the company contacted the supermarket chain involved to stop its sale and account for the entire product belonging to that vat. The recalled “Queso de Mano Paisa” was only sold in Utah, at Rancho Markets stores. The product is packaged in a 24-ounce plastic container. BEST BY MAY 16, 2024. The recall was initiated after one laboratory analysis revealed suspicion that that lot sample was contaminated. After a second analysis, the presence of Listeria monocytogenes was confirmed. No illnesses have been reported to date in connection with this problem. @ https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/tama-corporation-recalls-product-because-possible-health-risk

The Meatingplace reported that the USDA/FSIS has issued its final rule on Salmonella as an adulterant in raw breaded stuffed chicken products, declaring that when the bacteria exceed 1 CFU per gram or higher for Salmonella contamination. In a news release, the agency said the final rule will go into effect 12 months after publication in the Federal Register; publication is likely next week. The announcement caps a long, controversial effort to stem the incidence of consumers becoming ill from eating raw poultry products that may appear cooked and not handled appropriately or fully cooked in the home. One change in the final rule is that FSIS will carry out verification procedures, including sampling and testing the raw incoming chicken component of these products, before stuffing and breading, instead of testing the original product. In a statement released today, NCC President Mike Brown said it is “gravely concerned that the precedent set by this abrupt shift in longstanding policy has the potential to shutter processing plants, cost jobs, and take safe food and convenient products off shelves. [Meanwhile,] the agency has no idea if this will move the needle on public health.” NCC estimates that on an annual basis, more than 200 million servings of this product will be lost, 500 to 1,000 people will lose their jobs, and the annual cost to industry will be significantly higher than USDA’s estimates. @https://www.meatingplace.com/Industry/News/Details/114333